Actively Recruiting
Circulating Tumor HPV DNA Guided Treatment Deintensification After Transoral Surgery for HPV-Positive Oropharyngeal Squamous Cell Carcinoma
Led by Indiana University · Updated on 2025-07-31
120
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a phase II trial to assess how well treatment deintensification guided by circulating tumor HPV DNA (ctHPVDNA) levels works for patients with HPV-positive oropharyngeal squamous cell carcinoma (OPSCC) who have surgery involving the oropharynx and neck dissection. This study aims to explore if reducing or stopping additional treatment based on ctHPVDNA results can maintain or improve outcomes while lowering treatment side effects and improving quality of life. Participants are assigned to different groups based on their postoperative ctHPVDNA levels and surgical pathology results. Those with undetectable ctHPVDNA and four or fewer affected lymph nodes receive no further treatment. Patients with undetectable ctHPVDNA but five or more positive nodes or confirmed extranodal extension receive a lower dose of radiation (30 gray). Those with detectable ctHPVDNA undergo imaging to check for operable disease and may have additional surgery. Depending on repeat ctHPVDNA results and nodal status, they may receive observation, 30 gray, or 40 gray radiation therapy. During the study, participants are monitored with blood tests for ctHPVDNA and undergo imaging and surgery as needed. Researchers will assess disease-free survival up to 24 months after surgery, along with local-regional control, overall survival, distant metastasis, adverse events, swallowing-related quality of life, and gastrostomy tube dependence. Safety monitoring occurs up to 6 months post-surgery, and quality of life is evaluated at several intervals up to 24 months, providing comprehensive assessment throughout the study period.
CONDITIONS
Brief Title
ctHPVDNA in HPV Positive Squamous Cell Carcinoma of the Oropharynx
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of consent
- Ability to provide written informed consent and HIPAA authorization
- ECOG performance status between 0 and 2
- Primary tumor in the oropharynx (palatine tonsil, tongue base, soft palate, lateral or posterior walls)
- Histologically confirmed squamous cell carcinoma
- Detectable ctHPVDNA from blood before treatment
- Tumor is resectable with high probability of negative margins
- Includes smokers and non-smokers
- Tumor stage T1 or T2, and selected mobile T3 tumors not invading the larynx
- Nodal stage N0, N1, or N2 with mobile neck nodes if positive
- HPV-positive tumor confirmed by p16, in-situ hybridization, PCR, or ctHPVDNA
- Subjects with unknown primaries included if primary is identified and resectable with negative margins or tonsils fully resected and negative
You will not qualify if you...
- Serious medical condition preventing general anesthesia for surgery
- History of head and neck radiation or head and neck cancer within the past 3 years
- Presence of distant metastatic disease
- Synchronous HPV-positive oropharynx primaries
- Prior invasive malignant disease within 3 years except cured non-melanoma skin or thyroid cancer
- Lactating or pregnant women
- Women of childbearing potential without a negative pregnancy test on surgery day, unless they have had hysterectomy, bilateral oophorectomy, or have been naturally amenorrheic for at least 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo transoral surgery to remove HPV-positive oropharyngeal squamous cell carcinoma.
1 surgery visit
Duration - Up to 6 weeks post-surgery
Participants receive personalized post-surgical treatment based on ctHPVDNA test results and pathology, which may include observation, deintensified radiation (30 or 40 Gray), or additional surgery followed by radiation as needed.
Multiple visits depending on treatment assignment
Duration - Up to 24 months post initial surgery
Participants are monitored for disease-free survival, local-regional control, overall survival, adverse events, and quality of life for up to 24 months after initial surgery.
Visits at 3, 6, 12, and 24 months post-surgery
Trial Site Locations
Total: 2 locations
1
IU Health Joe and Shelly Schwarz Cancer Center
Carmel, Indiana, United States, 46032
Actively Recruiting
2
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
A
Azeezat Yekinni
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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